Haematological Indices in Systemic Lupus Erythematosus

September 27, 2019 updated by: AA Mohamed, Assiut University

Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity

The aim of this study is to investigate the value of several hematological indices such as:

  • neutrophil-lymphocyte ratio.
  • platelet-lymphocyte ratio.
  • red blood cell distribution width.
  • mean platelet volume (MPV), RDW/platelet ratio.
  • neutrophil / C3 ratio.
  • All these as biomarkers of activity in systemic lupus erythematosis patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations of the patients.

The pathogenesis of SLE remains unclear, but environmental triggers and genetic factors contribute to the destruction of immune tolerance systems, the production of immunological lymphocytes, antibodies, and inflammatory cytokines.

The clinical manifestations of SLE range from constitutional symptoms, such as fever, sweats, weight loss, joint pain and skin rashes (including the classic butter fly rash), to more serious features, including the involvement of the central nervous system and kidneys.

However, to make a clinical diagnosis of SLE, The SLICC criteria require either that a patient satisfy at least 4 of 17 criteria, including at least 1 of the 11 clinical criteria and one of the six immunologic criteria, or that the patient has biopsy-proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA) or anti-double-stranded DNA (dsDNA) antibodies. Patients with higher disease activity often present severer damage of tissues and organs.

SLE is characterized by high heterogeneity, a complex pathophysiology and various clinical manifestations; thus, no test alone is sufficiently sensitive or specific for diagnosis. Active and inactive SLE patients were evaluated according to SLE disease activity index (SLEDAI).There is significant interest in the identification of biomarkers that can predict SLE and quantify disease activity.

Neutrophils and lymphocytes play major roles in inflammatory processes. Under inflammatory conditions, neutrophil and lymphocyte counts undergo temporary changes. Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.

As an index of systemic inflammation, NLR has been identified to be a useful index for the differential diagnosis or prognostic prediction of diseases. NLR can be calculated easily and less costly as compared with detection of other inflammatory cytokines that could be used as biomarkers for inflammatory response or disease activity in SLE patient.

The platelet-to-lymphocyte ratio (PLR), red blood cell distribution width (RDW), and similar parameters [ eg, neutrophil-to-lymphocyte ratio (NLR) and mean platelet volume (MPV) ], which can be easily obtained using peripheral blood parameters, have been regarded as novel, accurate inflammatory biomarkers in many diseases.

MPV is a biomarker of platelet turnover, whereas platelet activation is a marker of inflammation. Previous studies have reported that MPV is correlated with the inflammatory process and disease activity in RA and ankylosing spondylitis, but the relationship between MPV and SLE remains controversial.

Complement system activation, production and partial deposition of complement fragments, and subsequent inflammation all play critical roles in the pathogenesis of SLE. During the complement activation pathway, Complement 3 was at the core position.

Study Type

Observational

Enrollment (Anticipated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

42 systemic lupus patients divided into two groups. The first group with active disease and the second group with inactive. There are 42 healthy participants age and sex matched as control group.

Description

Inclusion Criteria:

  • 1. SLE patients who fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (Petri et al., 2012).
  • 2. All patients > 18 years old.

Exclusion Criteria:

  • 1. Patients with other autoimmune disease such as: Rheumatoid arthritis (RA), Mixed connective tissue disease (MTCD), Dermatomyositis (DM) and Systemic Sclerosis (SS).
  • 2. Patients with malignant diseases.
  • 3. Patients with coronary artery disease, cerebrovascular disease, renal and liver diseases.
  • 4. Patients with evidence of any concomitant inflammatory disease. Acute infection or chronic inflammatory status.
  • 5. Patients with hematological disease or history of blood transfusion in the previous 4 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
active systemic lupus erythematosus
Other: Systemic lupus erythematosus disease activity index (SLEDAI)
The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease
inactive systemic lupus erythematosus
Other: Systemic lupus erythematosus disease activity index (SLEDAI)
The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological indices and their association with activity in systemic lupus erythematosis patients.
Time Frame: baseline
investigate the value of several hematological indices and their association with activity in systemic lupus erythematosis patients.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haematological indices

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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